Last updated: May 28, 2026
Executive summary
EDARBI (azilsartan medoxomil) is marketed in the U.S. as tablets and is sourced through a multi-stage supply chain: API manufacture (azilsartan medoxomil), intermediate and solid-dosage formulation manufacture, and finished-product packaging and release. The highest-confidence supplier identification for EDARBI is made through FDA drug-approval filings and Orange Book–linked manufacturing/release listings; without those specific FDA listing records for the exact product/strength and labeler, a complete supplier roster cannot be produced accurately.
Which companies are listed as suppliers for EDARBI (azilsartan medoxomil) on the Orange Book?
Answer: Supplier identification for EDARBI must come from Orange Book “Applicant/Manufacturer/Labeler” and FDA application manufacturing site listings for the marketed tablet strengths.
What supplier roles appear for EDARBI tablets in FDA listing data?
EDARBI tablet supply-chain listings typically split across:
- Labeler/applicant (the FDA-registered marketing entity)
- Manufacturer of finished dosage form (site that makes tablets)
- Packager (if different)
- Repackager (if different)
- API manufacturer (listed via application chemistry and FDA drug substance sections, and sometimes via DMF-linked references)
How to map “labeler” vs “manufacturer” vs “API supplier” for EDARBI
A supplier roster that is useful for sourcing, licensing, or litigation should separate:
- Commercial manufacturer (finished tablets, packaging, release)
- Drug substance supplier (azilsartan medoxomil API and relevant intermediates)
- Contract manufacturing organization (CMO) sites (if used)
- GMP release/testing roles (often not visible without detailed site listings)
Who supplies azilsartan medoxomil (EDARBI API) for EDARBI tablets?
Answer: The EDARBI API supplier list is tied to FDA drug substance references (often via DMFs or in the NDA/ANDA chemistry section). EDARBI’s API supplier cannot be stated without the specific FDA listing/DMF data for the marketed strengths.
What “API supplier” information is usually discoverable
Commonly discoverable items in FDA records:
- DMF holder for azilsartan medoxomil (if referenced)
- Manufacturer name(s) and sites for drug substance
- Evidence of changes across supplements and manufacturing site transfers
What to use for supplier validation in EDARBI sourcing
For high-stakes decisions, the supplier you sign is validated by:
- FDA-approved manufacturing site listed for the dosage form
- DMF-linked drug substance manufacturer for azilsartan medoxomil
- Consistency across supplements and annual reports
Which contract manufacturers produce EDARBI tablets (finished dosage form)?
Answer: Finished dosage form producers are listed in FDA application manufacturing sections and Orange Book manufacturing site listings. A definitive set of CMO names for EDARBI requires the exact FDA record for each tablet strength.
How EDARBI tablet strengths affect supplier mapping
EDARBI is marketed in multiple strengths. Supply-chain records can vary by:
- strength manufacturing line
- packaging configuration
- release testing and quality control sites
What manufacturing sites supply EDARBI packaging and release?
Answer: Packaging and release are distinct supply-chain functions, and the relevant sites are listed under packaging/manufacturing sections for the EDARBI product application.
What “packager” vs “manufacturer” means in EDARBI sourcing
- A site may manufacture tablets but not package them.
- A site may package but not compound.
- Testing/release can be performed at one or multiple sites based on FDA approval.
Are there multiple EDARBI suppliers due to manufacturing changes or site transfers?
Answer: Yes, high-volume branded products often show manufacturing site transfers over time. EDARBI supplier changes are evidenced only by FDA supplements that add or transfer manufacturing responsibilities.
What evidence shows supplier plurality in FDA records
- Supplement approvals adding dosage form manufacturing sites
- API DMF amendments or replacement references
- Revisions to labeling that reflect site changes
Which countries supply EDARBI manufacturing inputs (API and finished tablets)?
Answer: Geographic supply depends on where FDA-listed sites are located. A complete country-by-country supplier map requires the actual FDA site address records for the EDARBI NDA.
What “country of origin” data is typically available
- GMP site address by company
- Packaging release location by lot history (usually not public without lot traceability)
What patent and regulatory status affects EDARBI sourcing and approved manufacturers?
Answer: EDARBI is a small-molecule hypertension therapy subject to NDA exclusivity and patent estates, but those legal details do not by themselves identify suppliers. Supplier identification still relies on FDA manufacturing and Orange Book listings.
How EDARBI exclusivity influences generic or alternative sourcing
When patents or exclusivity restrict generic entry, the marketed product manufacturing and labeler remain the principal supply. Over time, manufacturing transfers can still occur without generics.
How strong is the EDARBI supply-chain barrier to entry for generics and competitors?
Answer: For suppliers, the practical barrier is FDA-approved manufacturing sites and drug substance references. Legal IP affects competitor products, but the ability to source is enforced through regulatory approval and quality systems tied to specific approved manufacturing routes.
What competitors must clear to source EDARBI-equivalent tablets
- Approved manufacturing site(s) under the competitor application
- Drug substance compliance for azilsartan medoxomil API
- Formulation and process robustness for tablets meeting specifications
Key takeaways
- EDARBI supplier identification must be grounded in FDA Orange Book and application manufacturing listings that show labeler, finished dosage form manufacturers, packagers, and drug substance references.
- Without the specific FDA product/strength listing records for EDARBI, a complete and accurate supplier roster cannot be produced.
- For sourcing, litigation, or licensing decisions, map suppliers by functional role: labeler/applicant, finished dosage form manufacturer, packager/repackager, and azilsartan medoxomil API (drug substance) manufacturer.
FAQs
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What does the Orange Book list for EDARBI that identifies manufacturers?
It lists the NDA labeler/applicant and often manufacturing site roles for the marketed strengths, which is the starting point for supplier mapping.
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How can I identify the EDARBI API supplier for azilsartan medoxomil?
By linking the EDARBI NDA’s drug substance reference to DMF or application chemistry/manufacturer sections in FDA records tied to the marketed product.
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Do different EDARBI strengths have different manufacturing suppliers?
They can, due to site- or line-specific manufacturing and packaging configurations reflected in FDA supplements.
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Where do packaging and release suppliers appear for EDARBI?
In the FDA manufacturing and packaging sections for the EDARBI application, often separate from finished dosage form manufacture.
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Does EDARBI’s patent status determine who supplies it?
Patent status affects market entry for generics and competitors, but supplier identity is determined by FDA-approved manufacturing and drug substance references, not by patents alone.
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book database).
